510(k) · Cleared
ClearedOrthophos SL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · OAS X-Ray, Tomography, Computed, Dental
Cleared on May 8, 2015 as substantially equivalent to K103711 (Sirona Dental Systems GmbH, 2011) and 1 other predicate after a 98-day review. Its family tree reaches back 7 generations to 1997. 5 later devices descend from it.
- Decided
- May 8, 2015
- Review
- 98 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K973642 (1997). 16 ancestors in all, the oldest K972312 (1997). 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 6 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 5 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 4 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 3 generations backK102124 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2010
- 2 generations backK120263 Volux 21C, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2012
- 1 generation backK123070 Galileos FamilySirona Dental Systems GmbH · 2013
- This deviceK150217 Orthophos SLSirona Dental Systems GmbH · 2015
- Descendant · cites it directly · 1 of its ownK201140 AxeosDentsply Sirona · 2020
- Descendant · 2 generations on · 0 of its ownK253959 Primevision 3DDentsply Sirona · 2026
- Descendant · cites it directly · 0 of its ownK213579 Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L · 2022
- Descendant · cites it directly · 0 of its ownK191616 Orthophos SDentsply Sirona · 2019
- Descendant · cites it directly · 0 of its ownK161131 FONA Pan/CephFona S.R.L · 2016
Most influential descendants
Showing 5 of 5 · See all- K201140AxeosDentsply Sirona · 2020 · cites it directly1descendant
- K253959Primevision 3DDentsply Sirona · 2026 · 2 generations on0descendants
- K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L · 2022 · cites it directly0descendants
- K191616Orthophos SDentsply Sirona · 2019 · cites it directly0descendants
- K161131FONA Pan/CephFona S.R.L · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −6 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −5 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −4 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −3 | K102124 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2010 | — |
| −2 | K120263 | Volux 21C, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2012 | — |
| −1 | K123070 | Galileos Family | Sirona Dental Systems GmbH | 2013 | — |
| 0 (this device) | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
| +1 | K201140 | Axeos | Dentsply Sirona | 2020 | — |
| +2 | K253959 | Primevision 3D | Dentsply Sirona | 2026 | — |
| +1 | K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | Fona S.R.L | 2022 | — |
| +1 | K191616 | Orthophos S | Dentsply Sirona | 2019 | — |
| +1 | K161131 | FONA Pan/Ceph | Fona S.R.L | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OAS device
- #1 K213226 RCT700score 18.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103711 | Orthophos XG 3D / CephSummary page 4…0 - Computed Tomography X-ray system Product Code: OAS – X-ray, Tomography, Computed, Dental 3 PREDICATE DEVICES Sirona ORTHOPHOS XG 3D / Ceph (K103711) Classification Number: 21 CFR 892.1750 - Computed Tomography X-ray system Product Code : OAS Sir… | 2011 |
| * | K123070 | Galileos FamilySummary page 4…Classification Number: 21 CFR 892.1750 - Computed Tomography X-ray system Product Code : OAS Sirona GALILEOS Comfort Plus (GALILEOS Family - K123070) Classification Number: 21 CFR 892.1750 - Computed Tomography X-ray system Product Code : OAS Th… | 2013 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K201140 (Dentsply Sirona, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K103711.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including
pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpus exposures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150217: Orthophos SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150217
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026